BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 3941417 · Received April 16, 2014

    Report

    Report Number
    3003312341-2014-00004
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 15, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K101705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DID NOT PASS THE ELECTRICAL SAFETY INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232606 MISTRAL-AIR PLUS (115V) BLOWER MISTRAL-AIR PLUS (115V) BLOWER DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1